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Last Updated: July 21, 2024

Testosterone enanthate - Generic Drug Details


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What are the generic drug sources for testosterone enanthate and what is the scope of patent protection?

Testosterone enanthate is the generic ingredient in three branded drugs marketed by Endo Pharms, Eugia Pharma, Hikma Farmaceutica, Nexus, Rising, Watson Labs, Watson Pharms Inc, and Antares Pharma Inc, and is included in nine NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Testosterone enanthate has ninety-four patent family members in fourteen countries.

There are eight drug master file entries for testosterone enanthate. Three suppliers are listed for this compound.

Drug Prices for testosterone enanthate

See drug prices for testosterone enanthate

Recent Clinical Trials for testosterone enanthate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The University of Texas Medical Branch, GalvestonPhase 2/Phase 3
University of FloridaPhase 2
North Florida/South Georgia Veterans Health SystemPhase 2

See all testosterone enanthate clinical trials

Pharmacology for testosterone enanthate
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists

US Patents and Regulatory Information for testosterone enanthate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 085599-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for testosterone enanthate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 ⤷  Sign Up ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 ⤷  Sign Up ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 ⤷  Sign Up ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 ⤷  Sign Up ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 ⤷  Sign Up ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for testosterone enanthate

Country Patent Number Title Estimated Expiration
Israel 184765 PREFILLED NEEDLE ASSISTED JET INJECTOR ⤷  Sign Up
Spain 2886553 ⤷  Sign Up
Japan 2023052550 テストステロン組成物の針に補助されるジェット注射投与 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2013169804 ⤷  Sign Up
Portugal 3659647 ⤷  Sign Up
Japan 6338658 ⤷  Sign Up
European Patent Office 4186545 ADMINISTRATION PAR INJECTION PAR JET ASSISTÉE PAR AIGUILLE DE COMPOSITIONS DE TESTOSTÉRONE (NEEDLE ASSISTED JET INJECTION ADMINISTRATION OF TESTOSTERONE COMPOSITIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.